CelluliteNCT05959681
Longitudinal Trial Assessing Cellulite in Women Wearing a New Compression Garment
A study testing Compression garment with Vari-pad microdots ink-printed on inside. in people with Cellulite, run by The Whiteley Clinic at 1 site in United Kingdom.
Trial summary
The investigators are investigating a compression garment that appears to reduce the appearance of Cellulite. The garment has both compression and patented ink-printed micro-dots ("Vari-pads"). These Vari-pads on the inner aspect of the garment are thought to increase the lymphatic return over compression alone. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite
- What is being tested?
- Compression garment with Vari-pad microdots ink-printed on inside.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2023to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Biological females, over the age of 18 years old, who are able to walk normally and who have cellulite on their buttocks and/or upper thighs.
- Due to having to produce special garments for this trial where only half of the garment has the Vari-pads, there will be for following restrictions:
- Total number = 60.
- Volunteers will be asked their sizes (Small, Medium, Large and Extra large) and will only be invited to attend if there are available places in that category.
- Sizes:
- Small = 10
Show all 9Show fewer
- Medium = 20
- Large = 20
- Extra large = 10
Who cannot join
- Women under 18 years of age.
- Women who are pregnant or who intend to get pregnant in the next 6 months.
- Women with no discernible cellulite on initial examination.
- Women undergoing any other treatment which aims to reduce the appearance of cellulite.
- Women who are unable to complete at least 3 months of this trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Whiteley Clinic
Guildford, GU2 7RF
Mark S Whiteley, MS FRCS MBBS, 0330 0581 850, mark@thewhiteleyclinic.co.uk
About this study
Official title: Longitudinal Trial Assessing Cellulite in Women Wearing a New Compression Garment - One Side With Ink Printed Micro-pads ("Vari-pads") and One Side Without.
The investigators are investigating a compression garment that appears to reduce the appearance of Cellulite. The garment has both compression and patented ink-printed micro-dots ("Vari-pads"). These Vari-pads on the inner aspect of the garment are thought to increase the lymphatic return over compression alone.
In this study, volunteers with cellulite are asked to wear the garment, with only one side (left or right) having the active Vari-pads. The participants wear the garment for at least 8 hours per day. If, and when, the participants notice a difference between the sides (left and right sides), the participants will notify the investigators. At this point the participants will be invited to the trial centre for an assessment and to be swapped to a garment with Vari-pads on both sides.
Apart from this variable end-point, the participants will be reviewed routinely at 3 and 6 months. The trial ends at 6 months.
Read the detailed description
The product being tested is to be a retail (non-medical) garment. This garment is a pair of standard compression shorts with a pattern of small, raised pads ("Vari-pads") of different heights printed on the inner aspect. A previous trial has suggested that wearing this garment for over eight hours a day can reduce the appearance of cellulite. In addition, participants found these compression pants to be very comfortable.
In this proposed trial, the investigators wish to investigate whether the previously found subjective and objective improvement of the appearance of cellulite is due to the compression alone, or whether the Vari-pads on the inside of the product enhance the subjective or objective impression of cellulite. As such, the investigators have asked the manufacturer to produce 60 pairs of pants where the Vari-pads are printed onto the inner aspects as per usual on one side, but not on the other side. On this other side, there will be a dot of the same colour printed, but it will not be raised.
The participants will be asked to wear the apparel for eight hours or more a day, at times that the participants find most suitable.
If and when the participants notice a difference in the appearance of cellulite between the right and left side, the participants will notify the investigators. At this point the investigators will invite the participants to the trial centre for an assessment. The participants will be swapped into the normal garments which have Vari-pads on both sides. The participants will then wear these garments for the remainder of the trial.
- Conditions
- Cellulite
- Being tested
- Compression garment with Vari-pad microdots ink-printed on inside.
- Keywords
- compression
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression garment with Vari-pad microdots ink-printed on inside.Device
Initially, participants wear a garment with Vari-pads on one side (left or right) only and swap to a garment with Vari-pads on both sides if / when the participants notice a difference between the sides. Wearing garment 8 hours per 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Experimental | A cohort of 60 biological females who volunteered to be part of the 6 months study. Receives: Device: Compression garment with Vari-pad microdots ink-printed on inside. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to subjective improvement on side with Vari-pads
Time to notice difference in cellulite between the sides when wearing garment with one side having Vari-pads.
Measured: 0-6 months
Secondary outcomes (3)
Quality of life changes
Quality of life changes by Celluqol® questionnaire at 0, 3 and 6 months.
The Celluqol tool gives a numerical outcome 8-40:
From 8 to 16 points - cellulite does not affect quality of life From 16 to 24 points - cellulite slightly affects quality of life From 24 to 32 points - cellulite reasonably affects quality of life From 32 to 40 points - cellulite intensely affects quality of life
Measured: 0-6 months
Objective clinical assessement of photographs by 2 blinded observers
Changes in photographs 0,3,6 months as assessed by 2 blinded observers who are clinicans expereinced in cellulite assessment. Each photograph will be blinded by a numerical code and blinded assessment will be by scoring 0-10. 0 is the worst posisble cellulite and 10 being no cellulite visible at all.
Measured: 0-6 months
Transcutaneous water content
Changes in transcutaneous water measurements - this is a numerical meaurement direct from the device.
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CelluliteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective observational cohort study.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Whiteley Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Whiteley, The Whiteley Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959681
- Sponsor's protocol ID
- TWC-SM-2023-01
- Status last verified
- Jul 2023
- First submitted
- 28 Jun 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arora G, Patil A, Hooshanginezhad Z, Fritz K, Salavastru C, Kassir M, Goldman MP, Gold MH, Adatto M, Grabbe S, Goldust M. Cellulite: Presentation and management. J Cosmet Dermatol. 2022 Apr;21(4):1393-1401. doi: 10.1111/jocd.14815. Epub 2022 Feb 14.
PubMed 35104044Kiely MJ, Poulsen A, Muschamp SD, Sallis C, Whiteley MS. Participant Reported Improvement in Cellulite by Vari-Pad Apparel and Objective Measurements - A "First Use" Pilot Study. Clin Cosmet Investig Dermatol. 2023 Sep 20;16:2573-2583. doi: 10.2147/CCID.S426978. eCollection 2023.
PubMed 37750084Nurnberger F, Muller G. So-called cellulite: an invented disease. J Dermatol Surg Oncol. 1978 Mar;4(3):221-9. doi: 10.1111/j.1524-4725.1978.tb00416.x.
PubMed 632386Hexsel D, Weber MB, Taborda ML, Dal'Forno T, do Prado DZ. Celluqol® - a quality of life measurement for patients with cellulite. Surgical and Cosmetic Dermatology 2011 (Jan);3(2):96-101
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Trial Assessing Cellulite in Women Wearing a New Compression Garment - One Side With Ink Printed Micro-pads ("Vari-pads") and One Side Without.
- ClinicalTrials.gov ID
- NCT05959681
- Acronym / sponsor ID
- TWC-SM-2023-01
- Conditions
- Cellulite
- Keywords
- compression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Whiteley ClinicUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are investigating a compression garment that appears to reduce the appearance of Cellulite. The garment has both compression and patented ink-printed micro-dots ("Vari-pads"). These Vari-pads on the inner aspect of the garment are thought to increase the lymphatic return over compression alone.
In this study, volunteers with cellulite are asked to wear the garment, with only one side (left or right) having the active Vari-pads. The participants wear the garment for at least 8 hours per day. If, and when, the participants notice a difference between the sides (left and right sides), the participants will notify the investigators. At this point the participants will be invited to the trial centre for an assessment and to be swapped to a garment with Vari-pads on both sides.
Apart from this variable end-point, the participants will be reviewed routinely at 3 and 6 months. The trial ends at 6 months.
Detailed description
The product being tested is to be a retail (non-medical) garment. This garment is a pair of standard compression shorts with a pattern of small, raised pads ("Vari-pads") of different heights printed on the inner aspect. A previous trial has suggested that wearing this garment for over eight hours a day can reduce the appearance of cellulite. In addition, participants found these compression pants to be very comfortable.
In this proposed trial, the investigators wish to investigate whether the previously found subjective and objective improvement of the appearance of cellulite is due to the compression alone, or whether the Vari-pads on the inside of the product enhance the subjective or objective impression of cellulite. As such, the investigators have asked the manufacturer to produce 60 pairs of pants where the Vari-pads are printed onto the inner aspects as per usual on one side, but not on the other side. On this other side, there will be a dot of the same colour printed, but it will not be raised.
The participants will be asked to wear the apparel for eight hours or more a day, at times that the participants find most suitable.
If and when the participants notice a difference in the appearance of cellulite between the right and left side, the participants will notify the investigators. At this point the investigators will invite the participants to the trial centre for an assessment. The participants will be swapped into the normal garments which have Vari-pads on both sides. The participants will then wear these garments for the remainder of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective observational cohort study.
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | Experimental | Device: Compression garment with Vari-pad microdots ink-printed on inside.A cohort of 60 biological females who volunteered to be part of the 6 months study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Biological females, over the age of 18 years old, who are able to walk normally and who have cellulite on their buttocks and/or upper thighs.
- Due to having to produce special garments for this trial where only half of the garment has the Vari-pads, there will be for following restrictions:
- Total number = 60.
- Volunteers will be asked their sizes (Small, Medium, Large and Extra large) and will only be invited to attend if there are available places in that category.
- Small = 10
Key exclusion criteria (5 listed)
- Women under 18 years of age.
- Women who are pregnant or who intend to get pregnant in the next 6 months.
- Women with no discernible cellulite on initial examination.
- Women undergoing any other treatment which aims to reduce the appearance of cellulite.
- Women who are unable to complete at least 3 months of this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression garment with Vari-pad microdots ink-printed on inside.Initially, participants wear a garment with Vari-pads on one side (left or right) only and swap to a garment with Vari-pads on both sides if / when the participants notice a difference between the sides. Wearing garment 8 hours per 24 hours. | Device | Study Cohort |
Primary outcome
Time to subjective improvement on side with Vari-pads
Time frame: 0-6 months
Time to notice difference in cellulite between the sides when wearing garment with one side having Vari-pads.
3 secondary outcomes
Quality of life changes
Time frame: 0-6 months
Objective clinical assessement of photographs by 2 blinded observers
Time frame: 0-6 months
Transcutaneous water content
Time frame: 0-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Background: PubMed 35104044Arora G, Patil A, Hooshanginezhad Z, Fritz K, Salavastru C, Kassir M, Goldman MP, Gold MH, Adatto M, Grabbe S, Goldust M. Cellulite: Presentation and management. J Cosmet Dermatol. 2022 Apr;21(4):1393-1401. doi: 10.1111/jocd.14815. Epub 2022 Feb 14.
- Background: PubMed 37750084Kiely MJ, Poulsen A, Muschamp SD, Sallis C, Whiteley MS. Participant Reported Improvement in Cellulite by Vari-Pad Apparel and Objective Measurements - A "First Use" Pilot Study. Clin Cosmet Investig Dermatol. 2023 Sep 20;16:2573-2583. doi: 10.2147/CCID.S426978. eCollection 2023.
- Background: PubMed 632386Nurnberger F, Muller G. So-called cellulite: an invented disease. J Dermatol Surg Oncol. 1978 Mar;4(3):221-9. doi: 10.1111/j.1524-4725.1978.tb00416.x.
- BackgroundHexsel D, Weber MB, Taborda ML, Dal'Forno T, do Prado DZ. Celluqol® - a quality of life measurement for patients with cellulite. Surgical and Cosmetic Dermatology 2011 (Jan);3(2):96-101
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression garment with Vari-pad microdots ink-printed on inside. in people with Cellulite, run by The Whiteley Clinic at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark S Whiteley, MS FRCS MBBS (03300581850, mark@thewhiteleyclinic.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to subjective improvement on side with Vari-pads (time frame: 0-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05959681, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.